NCT00461955已完成2 期
Pilot Clinical Trial of Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation in Adult Patients With Multiple Myeloma in First Response
University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2007年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of in vitro amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of in vitro amplified graft, without transfusion.
研究概览
简要总结
Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of ex vivo amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of ex vivo amplified graft, without transfusion.
详细描述
To check that injection of autologous peripheral blood stem cell CD34(+) "amplified ex vivo in the presence of SCF, G-CSF and TPO in HP01 Maco pharma medium culture. ": Allows to obtain a hematopoietic reconstitution:
- Rapid : 7 days or less after the injection, regarding neutrophils and 15 days or less regarding platelets
- Complete: numbers neutrophils and platelets respectively higher than 500/mm3 and 20000/mm3 within the times mentioned
- Stable: no secondary neutropenia or thrombocytopenia during the year following the injection, in the absence of recurence of the myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 18 and 65 years of age
- •Diagnosis of Multiple Myeloma, requiring a treatment, including high dose Melphalan whith autologous peripheral blood stem cell transplantation
- •Performance status: < 2 (Karnofsky > 70%)
- •Anticipated survival > 3 month
- •Collection of a minimum of 10x106 cells (CD34+)/Kg of autologous G-CSF mobilised peripheral blood stem cells in 2 to 3 pheresis.
- •Signed and dated informed consent
排除标准
- •Multiple Myeloma not requiring a treatment
- •Another cancer in the 5 years preceding the diagnosis or evolutive psychiatric affection
- •Positive serology for HIV, hepatitis C or hepatitis B
- •Hepato cellular insufficiency
- •Severe renal insufficiency defined by a creatine clearance < 30 ml/mn
- •Women pregnant or nursing, or effective absence of contraception
- •Antecedent of serious cardiac disease in the last 6 months.
- •Allergy known to the products derived from Escherichia Coli
研究组 & 干预措施
1
Experimental
autologous peripheral blood stem cell transplantation
干预措施: autologous peripheral blood stem cell transplantation, ex vivo amplified (Procedure)
结局指标
主要结局
Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of in vitro amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of in vitro amplified graft, without transfusion.
时间窗: at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft
次要结局
- Immediate Toxicity of the injection of the amplified graft ;(just after the injection of the amplified graft)
- Quantitative immunological Reconstitution(at day 30, 100, 180, 270, 360 after the injection and then every 6 months)
- Stability of the hematopoiesis in the long term(at 1, 3, 6, 9 and 12 months after the graft)
- Absence of cytogenetics abnormalities not related to the multiple myeloma in the long term.(at 1, 3, 6, 9 and 12 months after the injection)
研究者
研究点 (1)
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